engthening Adalimumab Dosing Interval in IBD patients in long term remission, the LADI study. - LADI study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Age 18 or older
•Written informed consent.
•Previous diagnosis of ileocolonic Crohn*s disease or ulcerative colitis
•In sustained clinical remission for at least 6 months whilst being treated with adalimumab
•Adalimumab dosed at 40mg, once every 2 weeks
•Full clinical response and disease control, defined as
•-Absence of intestinal or extra-intestinal symptoms, as judged by both patient and physician
•-Fecal calprotectin < 200 µg/g and CRP within normal range
•-Full endoscopic remission (no ulcera) assessed at least within 12 months before inclusion
•Permitted concomitant therapy: aminosalicylates, azathioprine, 6-mercatopurine and methotrexate at stable dose for 12 weeks

•Concomitant corticosteroid usage
•Imminent need for IBD-related surgery
•Actively draining perianal fistula
•Pregnancy or lactation
•Other significant medical illness that might interfere with this study (such as current malignancy, immunodeficiency syndromes and psychiatric illness)

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